Parasym tVNS, Быстрый старт, Страница: 6 / 22

POTENTIAL RISKS AND COMPLICATIONS
The Parasym device is considered low risk when used in accordance with the instructions for use. A low
incidence of skin irritation has been reported from using the Parasym device. No serious adverse events
have been reported. If you experience any side effects from device use stop treatment immediately. If in
doubt, contact your healthcare provider.
A 2018 systematic review analysed 1322 participants (across 51 studies) who received transcutaneous
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vagus nerve stimulation. NOTE: this review analysed studies using multiple different tVNS methodologies
so the results cannot be extrapolated to the Parasym device and are included only as reference
information for tVNS.
The review found that only only 2.6% of participants discontinued use due to side effects, where the most
common side effect reported was skin irritation at the stimulation site which typically ceased shortly after
use.
The following side effects were reported in this review with use of transcutaneous vagus nerve stimulation
devices:
Tingling/pain/redness/itching at the site of electrode placement during long term application (16.7%)
Lightheadedness/dizziness (1.4%)
Fatigue (0.5%)
Shortness of breath (0.4%)
Voice alteration/hoarseness (0.3%)
Abnormal heart rhythm (0.3%)
IF IN DOUBT CONSULT YOUR DOCTOR OR HCP.
Environmental Conditions:
Temperature :
Operating: 5 ~ 40
℃
Storage : -25 ~ 70
℃
R.H.ambient :
Operating: 15% ~ 93% RH
Storage : 0% ~ 93% RH
Altitude :
Operating: 700hPa to 1060hPA
Storage : 500hPa to 1060hPA
1 ​ Redgrave, J., Day, D., Leung, H., Laud, P. J., Ali, A., Lindert, R., & Majid, A. (2018). Safety and
tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain stimulation,
11(6), 1225-1238.
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